Differences Between Women and Men Taking a Combination of Indinavir, Ritonavir, Enteric-Coated Didanosine, and Stavudine Who Previously Took Anti-HIV Drugs

NCT ID: NCT00006397

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-31

Brief Summary

The purpose of this study is to see how safe and effective it is to give multi-drug treatment with indinavir (IDV) plus ritonavir (RTV) plus enteric-coated didanosine (ddI) plus stavudine (d4T) and if there are differences in responses between men and women.

Detailed Description

Patients are enrolled in balanced numbers based on gender and stratified by viral load (less than or equal to 10,000, 10,000 to 100,000, or more than 100,000 copies/ml). Prior to therapy, a peer-based patient education intervention is presented. Patients receive a combination of IDV, RTV, enteric-coated ddI, and d4T. Responses to this multi-agent antiretroviral drug regimen are explored based on sex differences. A pharmacokinetic sub-study, balanced so that half of patients are male and half are female, is performed on IDV and RTV for 20 to 25 of the patients. About 20 females are examined for study-drug effects on gonadotropic hormone levels.

Conditions

HIV Infections

Keywords

Didanosine; Drug Therapy, Combination; Stavudine; HIV Protease Inhibitors; Sex Factors; Ritonavir; Indinavir; Dosage Forms; Reverse Transcriptase Inhibitors; Anti-HIV Agents

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Indinavir sulfate

Intervention Type: DRUG

Ritonavir

Intervention Type: DRUG

Stavudine

Intervention Type: DRUG

Didanosine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.
• Have viral load (amount of HIV in the blood) greater than 500 copies/ml.
• Have received anti-HIV treatment previously with an NNRTI plus an NRTI combination or only NRTIs for greater than 8 weeks and, if not currently on treatment, have been off treatment for 12 weeks or less.
• Failed to keep their viral load low during previous anti-HIV treatment.
• Are at least 18 years of age.
• Agree to use an effective barrier method of birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have used a protease inhibitor for more than 14 days.
• Have used ddI or d4T for more than 30 days.
• Are pregnant or breast-feeding.
• Have an opportunistic (AIDS-related) infection requiring treatment at the time of enrollment.
• Have, or appear to have, peripheral neuropathy (a painful condition affecting the nervous system) at the time of screening.
• Are at risk for, or have had, pancreatitis (disease of the pancreas).
• Have difficulty absorbing medications.
• Have a cancer, other than Kaposi's sarcoma, that may require systemic treatment.
• Have any medical condition or treatment that may cause a rise in viral load.
• Have any other condition or previous treatment that would interfere with the study.
• Are unable to take drugs by mouth.
• Are receiving or have received recently any of the following drugs: terfenadine, astemizole, cisapride, triazolam, midazolam, ergot alkaloids, amiodarone, bepridil, flecainide, propafenone, quinidine, pimozide, rifampin, and intravenous (IV) pentamidine.
• Are receiving vincristine, thalidomide, foscarnet, or cisplatin or other medications that may cause nerve damage.
• Have received any experimental drug within 30 days prior to treatment.
• Are receiving treatment with testosterone, anabolic steroids, growth hormone, or megestrol acetate, except for certain hormonal problems.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PPD Development, LP

INDUSTRY

Sponsor Role: lead

Locations

East Bay AIDS Ctr

Berkeley, California, United States

Univ of Southern California

Los Angeles, California, United States

UCLA CARE Ctr

Los Angeles, California, United States

North Broward Hosp District / HIV Clinical Research

Fort Lauderdale, Florida, United States

Saint Josephs Comprehensive Research Institute

Tampa, Florida, United States

Louisiana State Univ Med Ctr / HIV Outpatient Clinic

New Orleans, Louisiana, United States

JSI Research and Training Institute

Boston, Massachusetts, United States

Univ of Med & Dentistry of New Jersey

Newark, New Jersey, United States

Beth Israel Med Ctr

New York, New York, United States

Harlem Hosp Ctr

New York, New York, United States

Univ of Rochester Med Ctr

Rochester, New York, United States

Vanderbilt Univ School of Medicine

Nashville, Tennessee, United States

Univ of Texas Southwestern Med Ctr

Dallas, Texas, United States

Ponce Univ Hosp

Ponce, , Puerto Rico

Univ of Puerto Rico School of Med

Rio Piedras, , Puerto Rico

Countries

United States; Puerto Rico

Other Identifiers

BMS 2000

Identifier Type: -

Identifier Source: secondary_id

312A

Identifier Type: -

Identifier Source: org_study_id